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Completed

NCT Number: NCT02249585

Effects of Neuromuscular Blockade Level and Intra-abdominal Pressure on Surgical Conditions and Cardiopulmonary Responses During Laparoscopic Colon Surgery With the Trendelenburg Position

The purpose of this study is to find out the effect of low abdominal pressure vs. standard abdominal pressure on the cardiac and respiratory function of the patients undergoing laparoscopic colon surgery in Trendelenberg position. It was also designed to evaluate the effect of the degree of neuromuscular blockade on the surgical condition of the patients undergoing laparoscopic colon surgery in Trendelenberg position.

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Key information

Conditions

Cardiac Index

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for laparoscopic colon surgery under Trendelenberg position

Exclusion criteria

  • ASA classification IV
  • Unable to make a written, informed consent
  • Allergic to neuromuscular blocking agents, anesthetics, opioids
  • Patients with neuromuscular disease
  • Hepatic failure
  • Renal failure
  • History of malignant hyperthermia
  • Morbid obesity with BMI>35 kg/m2
  • Patients enrolled in another clinical trials

Treatment and study plan

Standard abdominal pressure

Device

Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery

Low abdominal pressure

Device

Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery

Other names: Abdominal pressure

Conventional neuromuscular blockade

Drug

Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch

Deep neuromuscular blockade

Drug

Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch

Primary outcomes

  1. Cardiac Index

    Time frame: 30 min after onset of laparoscopy

    Cardiac index 30 min after onset of laparoscopy. The cardiac index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.

Secondary outcomes

  1. Mean Arterial Blood Pressure (MBP)

    Time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy

    Mean arterial blood pressure measured during laparoscopic surgery. The mean arterial blood pressure was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.

  2. Stroke Volume Index (SVI)

    Time frame: 1, 30, 60, 90, 120 min after onset of laparoscopy

    Stroke volume index during the surgery. The stroke volume index was measured with an arterial waveform analysis system (FloTrac/EV1000, version 4.0; Edwards Life Sciences, Irvine, CA, USA) from the radial artery.

  3. PaO2

    Time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy

    PaO2 measured during laparoscopic surgery. The PaO2 (arterial partial pressure of oxygen) was measured with the blood gas analyzer (GEM Premier 3000, Model 5700; Instrumentation Laboratory, Lexington, MA, USA).

  4. Pulmonary Compliance

    Time frame: 1, 30, 60, 90, and 120 minutes after onset of laparoscopy

    Pulmonary compliance during laparoscopic surgery. The pulmonary compliance was calculated from the plateau and peak inspiratory pressures, positive end-expiratory pressure, and tidal volume measured with an anesthetic machine (Primus; Dräger, Lübeck, Germany).

  5. Surgical Rating Scale

    Time frame: 1 min after laparoscopic procedure

    The surgical rating scale was assessed by the surgeon and graded as a five-point scale: optimal, good, acceptable, poor, and extremely poor conditions.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2014
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.